Apparatus for locating a breast mass

ABSTRACT

A mass localization device includes a catheter and a needle. In one embodiment, the catheter includes inner and outer walls spaced from each other and creating a gap between the walls extending along substantially the entire length of the catheter. The distal portion of the outer wall includes an inflatable balloon. In use, the balloon is positioned proximate the mass and inflated to make the mass palpable. An incision to the mass can be achieved by the shortest possible distance since the mass is made palpable.

This application is a divisional of application Ser. No. 07/948,320,filed Sep. 22, 1992, now U.S. Pat. No. 5,301,682, which is in turn adivisional application of application Ser. No. 07/604,092, filed Oct.29, 1990, now U.S. Pat. No. 5,183,463, which is in turn acontinuation-in-part application of my U.S. application Ser. No. 305,965which was filed on Feb. 3, 1989 entitled "Apparatus and Method forLocating a Breast Mass", now U.S. Pat. No. 4,966,583 of Oct. 30, 1990.

FIELD OF THE INVENTION

The present invention relates to a medical instrument for locating amass in body tissue so that the mass may be accessed or removed by themost direct or most appropriate incision from the epidermal layer to themass.

BACKGROUND OF THE INVENTION

Locating masses or tumors in human tissue is necessary for a biopsy ofthe suspicious mass and subsequent removal. Sometimes it is possible tolocate a mass merely by touching the skin above and around thesuspicious area. However, often the mass is too small to be noticed byhand or is located in fatty tissue that interferes with determining theprecise location of the mass. A specific example of the latter case isthe location of small breast masses or calcifications.

Typically, the precise location of these types of masses can only bedetermined by x-ray analysis, using specialized instrumentation prior toa surgical operation to locate the mass to be removed. Typically, a verythin needle is inserted into the breast down to the mass under x-raycontrol (mammography). Once it is determined by x-ray control that thetip of the needle is located at the mass site, the patient istransported to an operating room, where the surgeon creates an incisionin the breast by following along the path of the inserted needle with ascalpel until reaching the mass. This method often involves a very longincision and increases the risk of post-operative infection.

An alternate method of creating an incision to gain access to or removea breast mass is to study x-rays of the breast mass taken from variousangles. Based upon experience and notional extrapolation of the viewsfrom different angles of the breast mass, an incision is made in anattempt to cut along the most direct path to the mass.

Several devices exist for localizing masses in human tissue. See, forexample, U.S. Pat. Nos. 4,682,606 to DeCaprio, 3,890,970 to Gullen, and3,598,119 to White.

The DeCaprio patent discloses a surgical needle which is inserted into alocated mass and encircled by a cork screw device. The cork screw deviceis twisted around the mass until the tip of the worm of the screw isJust beyond the furthest side of the mass. Thereafter, the handle of thecork screw device is withdrawn and a guiding extension rod is replacedto direct the surgeon to the depth of the mass in the patient's tissue.Then, a cutting instrument is inserted over the extension rod forremoving the mass from the tissue.

The Gullen patent discloses a surgical cannula for delivery ofparacervical anaesthesia. The cannula includes a catheter having aclosed distal end with a perforated membrane. The distal end is firm andsharp enough to be inserted into body tissue to a predetermined depth,as limited by a stop member. A thin membranous ballooning portion isprovided proximate the distal end of the catheter for expansion uponapplication of a fluid pressure within the catheter to lock the cannulain place in the tissue. The device is left in the tissue of the patientby the ballooning portion to provide periodic supply of fluidanaesthesia during a surgical procedure.

Similar to the patent to Gullen, the White patent discloses a medicalinstrument for use in gynecological procedures to allow theadministration of a paracervical block, continuously or intermittently,with only a single placement. The device comprises an elongated hollowtube having an open distal end and receiving a needle for guiding thedevice into tissue. An inflatable bladder is provided near the distalend of the hollow tube for retaining the device in the tissue andminimizing trauma associated with the procedure.

The prior art devices discussed above provide a procedure for retaininga catheter type instrument in the tissue of a patient, but fail toprovide a procedure for precisely identifying a mass within the tissue.Moreover, the prior art devices are of an insufficient size toaccurately locate a mass within breast tissue prior to surgery.

SUMMARY OF THE INVENTION

It is a primary object of the present invention to provide a device foraccurately locating a mass within breast tissue prior to a surgicalprocedure for taking a biopsy of, or removing the mass.

According to one embodiment of the present invention, a catheter hasproximal and distal open ends for receiving a hollow needle insertableinto the catheter. An inflatable balloon is provided at the distalmostend of the catheter for expansion around the catheter at the distal endof the catheter. A source of sterile fluid (such as air or salinesolution) is connected to the catheter adjacent the proximal end of thecatheter, and has a separate port connection to the catheter.

Preferably, the inflatable balloon is formed as an outer layer or sheathextending along the length of the catheter. The distalmost end of theouter layer forming the inflatable balloon has a smaller thickness thanthe remainder of the outer layer. As such, upon the supply of fluid, thedistal end of the outer layer expands, while the remaining portion ofthe outer layer remains flush with the periphery of the catheter.

With the balloon deflated and flush with the periphery of the catheter,a hollow needle is inserted to extend beyond the distal end of thecatheter, and the device is inserted into the tissue to a positionadjacent the mass to be located. Typically, this is performed under thecontrol of x-ray (mammography) to precisely locate the mass. Once themass is located and the combined catheter and needle is moved adjacentto the mass, local anesthetic is applied through the needle to thetissue area surrounding the mass, and the balloon is then inflated toidentify the location of the mass. The needle can then be withdrawn. Theinflated balloon is felt by the surgeon to determine the location of themass.

In another embodiment of the present invention, a needle is insertedadjacent the mass, typically during the x-ray mammography while thebreast is under compression and then an anesthetizing agent isintroduced. A catheter having a balloon member at the distalmost end isthen inserted in the needle until the balloon is just inside the tip ofthe needle. Then the needle is withdrawn, typically while the breast isstill under compression. The proximal end of the catheter is preferablyconnected to a removable valve (such as a check valve) and the balloonis inflated to enable the surgeon to determine the location of the mass.

The above and other objects of the present invention will become moreapparent when reference is made to the following description, taken inconjunction with the accompanying drawings.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 is a perspective view of the mass localization device of thepresent invention;

FIG. 2 is a cross sectional view taken through line 2--2 of FIG. 1 andillustrating the inflatable balloon of the localization device in bothinflated and deflated states;

FIG. 3 is a partial sectional view of the mass localization device ofFIG. 1, and illustrating the inflatable balloon in its inflated state;

FIGS. 4 and 5 are exaggerated enlarged cross sectional viewsillustrating initial and final steps in employing the mass localizationdevice of the present invention for locating a mass in breast tissue;

FIG. 6 is a cross sectional view of a modified form of the masslocalization device of FIG. 2; and,

FIG. 7 is a cross sectional view of another mass localization deviceaccording to the present invention.

DESCRIPTION OF THE PREFERRED EMBODIMENTS

FIGS. 1-3 illustrate the mass localization device of the presentinvention, generally shown at 10. The localization device 10 includes arubber catheter 12 having a proximal open end 14 and distal open end 16,The catheter 12 includes an inner wall 18 and an outer wall 20. Theinner wall 18 and the outer wall 20 are connected together at proximalend 14 and distal end 16. Between the proximal end 14 and the distal end16 is a gap 22 located between the inner wall 18 and the outer wall 20.

The inner wall 18 has a substantially uniform cross section along itsentire length. The outer wall 20 includes a thickened ring 24 near thedistal end 16 of the catheter, which separates the outer wall 20 into aproximal portion 26 and a distal portion 28. The proximal portion 26 hasa greater thickness than the distal portion 28, which is more flexiblefor reasons described hereinafter.

A No. 25 gauge hollow needle 30 or the smallest gauge needle which isappropriate under the circumstances as will be apparent to one skilledin the art upon reading the present specification is provided having ahub 32 located at the proximal end of the needle 30, and a sharp opendistal end 34. The needle 30 has a length slightly greater than thecatheter 12. The catheter 12 has a length of 5, 10, 15, or 20 cm,depending on the size of the breast being operated on. The hollow needle30 is insertable through the proximal end 14 of the catheter 12 so thatthe sharp distal end 34 extends slightly beyond the distal end 16 of thecatheter 12.

The distal portion 28 of the outer wall 20 of catheter 12 forms aninflatable balloon at the distal end 16 of the catheter. A source offluid, preferably a source of sterile air 33 or a source of a sterilesaline solution or another liquid which preferably provides no sideeffects in case of a rupture of the balloon such as methylene blue, iscommunicated to the balloon 28 via a port 36 provided by a portextension 38 which attaches, or preferably is formed as part of theouter wall 20 of catheter 12. Upon supply of fluid through port 36, theballoon 28 expands to the position illustrated in FIG. 3, andillustrated in FIG. 2 in phantom at 28'. A preferred diameter of theballoon 28 is 2 to 5 cm. The thickened ring 24 allows only the balloon28 to expand, rather than both the balloon 28 and the proximal portion26 of the outer wall 20. When no supply of fluid is connected to port36, for expanding the balloon 28, the balloon 28 maintains a flushrelationship with the periphery of the catheter 12 as illustrated inFIGS. 1 and 2.

In use, the mass localization device 10 is inserted into body tissueunder x-ray control to be adjacent to a mass in the tissue. Once thedistal end of the device 10 is located proximate to the mass, localanaesthesia is supplied through needle 30 to the area adjacent the mass.The balloon 28 is then expanded to identify the location of the mass,and the needle 30 is removed. Thereafter, a surgeon can feel thelocation of the inflated balloon and form an incision from a point onthe skin located closest to the balloon so as to make as small anincision as possible to gain access to the mass.

FIGS. 4 and 5 illustrate a localization technique for non-palpablebreast masses employing the localization device 10 of the presentinvention. Initially, the needle 30 is inserted through the catheter 12so that the distal end of the needle extends slightly beyond the distalend 16 of the catheter 12. Under x-ray control, the localization device10 is inserted into the breast tissue 40 and maneuvered towards a mass42 as illustrated in FIG. 4. The device 10 is carefully moved towardsthe mass 42 so that the distal end 16 of the catheter 12 is proximatethe mass 42 as illustrated in FIG. 5. At this point, local anesthetic isinjected through the needle 30 to the suspicious area. Thereafter, thesupply of fluid 33 is connected to the port 36 for inflating the balloon28 to the position shown in FIG. 5. Now, the mass 42 is palpable since asurgeon can feel the mass 42 through the skin by feeling for theinflated balloon 28. The needle 30 is then withdrawn from the catheter12 and the patient is prepared for a surgical biopsy or other procedurewith the catheter left in place. As a result, the surgeon forms anincision which accurately provides for the most direct access (or themost appropriate access) to the mass so that the surgeon can take abiopsy of the suspicious area.

With reference now to FIG. 6, a valve 50 is preferably provided at oneend of the port extension 38. The valve 50 is preferably a suitable,conventional check valve which enables the catheter 20 to be suppliedwith fluid such as by inserting a needle of a syringe into the checkvalve and pushing the plunger into the syringe. Upon withdrawal of theneedle of the syringe from the check valve 50, the pressurized fluidwould remain in the catheter to maintain the balloon 28 in an inflatedcondition. The syringe may then be reinserted into the check valve 50 toprovide additional fluid under pressure or to remove fluid underpressure. The fluid under pressure would be removed by withdrawing theplunger while the needle of the syringe is inserted in the check valve.In this way, the check valve and the syringe permit the balloon at theend of the catheter to be inflated, maintained in an inflated condition,and deflated as desired.

In addition, the catheter 20 is covered by a sheath 52 which ispreferably made of latex. The sheath 52 covers the catheter from thedistal end 16 of the catheter to the port extension 38. In this way, thesheath facilitates insertion of the catheter into the body tissue andprevents or minimizes any crimping of the inflatable balloon. Ifdesired, after proper insertion of the catheter has been achieved, thesheath may be torn apart adjacent the extension port and withdrawn fromthe catheter. As the sheath is progressively pulled rearwardly and torn,the sheath is gradually removed from the catheter completely.Alternatively, the sheath may be torn apart and withdrawn only enough touncover the balloon at the distal portion of the catheter. The sheath ispreferably of a suitable, conventional form and may be provided with aweakened portion, such as a perforation running along the length of thesheath, to facilitate the tearing of the sheath.

With reference now to FIG. 7, another embodiment of a mass localizationdevice according to the present invention includes a needle 60. Theneedle 60 preferably has a length which is appropriate for the distancethat the needle is to be inserted into the breast or other body tissue.Typically, needles of various lengths will be available for use inconnection with the present invention with the needles having a lengthof about 5 centimeters to about 25 centimeters.

The needle 60 has a sharp point to facilitate insertion of the needleinto the breast or body tissue. The needle 60 also has an internaldiameter which is sufficient to pass a catheter 64 having a balloon 66which may be inflated so as to have a diameter of about 2 to 5centimeters or more.

The needle 60 may be connected to a syringe (not shown) by a suitable,conventional hub 61. For example, the hub 61 may be threaded so as tothreadably connect with a corresponding portion of the syringe. When theneedle 60 is connected to a syringe, an anesthetizing agent Or anotherfluid may be injected through the needle as desired. The syringe isremovable from the needle as described more fully below to facilitatethe insertion of the catheter 64 through the needle.

With the syringe removed (and after the needle has been inserted intothe breast tissue with the tip of the needle at the mass to belocalized), the catheter is inserted into the needle until the balloon66 which is provided at the distal end 68 of the catheter 64 is justwithin the tip of the needle 60. A mark 70 is provided on the catheterat a location which indicates that the balloon 66 is just within the tipof the needle. Preferably, the mark is located at the rearwardmost endof the hub 61 when the balloon is just within the tip of the needle 60.

If the catheter is sufficiently rigid, the catheter may be inserted intothe needle without the use of a stylette. However, if the catheter isnot sufficiently rigid, insertion of the catheter into the needle may befacilitated by providing a stylette 72 inside the catheter. The stylette72 has a blunt tip so as not to perforate the balloon 66.

When a stylette is used, the stylette 72 and the catheter 64 areinserted into the needle 60 as a unit. After the catheter is properlyinserted into the needle, the needle is removed by withdrawing theneedle over the catheter 64. In order to permit the needle to bewithdrawn, the catheter should have a length which is slightly more thantwice as long as the needle and the hub 61. If a stylette was used, thestylette is then removed by withdrawing the stylette from the catheter.If desired, the stylette may be removed prior to withdrawing the needlefrom the catheter.

After the needle and stylette have been withdrawn from the catheter, thecatheter is supplied with a pressurized fluid to inflate the balloon asdescribed above in connection with FIGS. 1-5. Preferably, a valve,especially a check valve as described above, is provided between the endof the catheter and the supply of pressurized fluid so as to enable theballoon to be readily inflated, maintained in an inflated condition andthen deflated as desired.

If the valve would obstruct the removal of the needle from the catheter,the valve should be releasably connected to the catheter. In this way,the valve may be disconnected from the catheter until after the needlehas been removed and the balloon is ready to be inflated.

The valve may be releasably connected to the catheter by a coupling 76which is received by the proximal end of the catheter. The coupling 76includes a portion which may be tapered or provided with a series ofridges so as to be frictionally retained within the catheter afterinsertion. Upon the use of sufficient force, however, the valve may beremoved from the catheter by pulling the coupling 76 out of the proximalend of the catheter.

The valve may be supplied with fluid under pressure as described abovein connection with FIG. 6. In this way, a syringe may be inserted intothe valve and the plunger depressed to inflate the balloon. Uponwithdrawal of the syringe from the valve, the balloon will remaininflated to anchor the catheter in the body tissue where desired.

In use, the needle of the mass localization device according to FIG. 7is inserted into the breast or other tissue preferably while the breastis undergoing x-ray mammography and is under compression. The needle isinserted until the tip of the needle is at the mass to be localized.Then an anesthetizing agent is injected into the body tissue such as bya syringe which is releasably connected to the needle. The syringe isthen disconnected from the needle and a catheter is inserted into theneedle. Insertion of the catheter may be facilitated by the use of astylette which is provided inside the catheter. When the catheter hasbeen positioned with the balloon (at the end of the catheter) Justwithin the tip of the needle, the needle is withdrawn and then thestylette is withdrawn. The catheter is then supplied with a sterilefluid to inflate the balloon as desired.

While the localization of breast masses has been specifically described,it is envisioned that the present invention can be employed forlocalizing masses in various other tissue environments.

The above description is intended by way of example only, and is notintended to limit the present invention in any way except as set forthin the following claims.

I claim:
 1. A medical apparatus comprising:a tubing having an openproximal end and an open distal end; an expandable balloon portionpositioned at a distalmost portion of said distal end of said tubing,said balloon portion being expandable around said tubing at saiddistalmost portion of said tubing and being inflatable to have adiameter of about 2 to 5 cm at a mass located deeply in the body tissue;and a hollow needle having proximal and distal ends, said distal endbeing sharp, said needle being insertable through said proximal end ofsaid tubing so that said distal end of said needle extends beyond saiddistal end of said tubing, with means for preventing the distal end ofsaid needle from extending more than slightly beyond said distal end ofsaid tubing.
 2. The apparatus of claim 1, further comprising a means forsupplying fluid to said balloon portion, said balloon portion beingexpandable upon receiving said fluid.
 3. The apparatus of claim 2wherein the fluid is air.
 4. The apparatus of claim 2 wherein the fluidis a liquid.
 5. The apparatus of claim 1, wherein said tubing includesan inner wall extending along the entire length of said tubing;an outerwall forming an external sheathing and being spaced from said inner walland extending along the entire length of said tubing, said inner walland said outer wall being connected together at said distal end andproximal end of said tubing, said outer wall including a thickenedportion to separate said outer wall into a proximal portion and a distalportion, said proximal portion having a thickness greater than athickness of said distal portion, and said distal portion of said outerwall forming said expandable balloon portion; and a gap formed betweensaid inner wall and said outer wall extending along substantially theentire length of said tubing and communicating with said distal portionwhich forms said expandable balloon portion.
 6. The apparatus of claim5, further comprising a port extension member and a supply of fluid,said port extension member being connected to said tubing forcommunicating said supply of fluid to said distal portion which formssaid expandable balloon portion via said gap between said inner wall andsaid outer wall.
 7. The apparatus of claim 1, wherein the distal end andthe proximal end of said needle are open.
 8. The apparatus of claim 1further comprising a sheath which is provided over the tubing andballoon member.
 9. The apparatus of claim 1 further comprising a latexsheath which is provided over the tubing and balloon member, the latexsheath being provided with a weakened portion along the length of thesheath to facilitate a tearing of the sheath during removal of thesheath from the tubing.
 10. The apparatus of claim 1 further comprisingvalve means for enabling the balloon to be maintained in an inflatedcondition.
 11. A medical apparatus comprising:a tubing having an openproximal end and an open distal end, said tubing including an inner wallextending along the entire length of said tubing, and an outer wallspaced from said inner wall and extending along the entire length ofsaid tubing, said inner wall and said outer wall being connected at saidproximal end and said distal end of said tubing, a gap created betweensaid inner wall and said outer wall extending substantially the entirelength of said tubing, said outer wall including distinct proximal anddistal portions, said distal portion being located at a distalmost endof said tubing and forming an inflatable balloon; a needle havingproximal and distal ends, said distal end being sharp, said needle beinginsertable through said proximal end of said tubing so that said distalend of said needle extends beyond said distal end of said tubing, withmeans for preventing said distal end of said needle from extending morethan slightly beyond said distal end of said tubing; and means forsupplying fluid to said inflatable balloon via said gap between saidinner and outer walls of said tubing, said inflatable balloon beingexpanded upon receiving said supply of fluid to identify the location ofa mass by positioning said tubing with said needle located thereinadjacent to the mass in the body tissue, said inflatable balloon beinginflatable to have a diameter of about 2 to 5 cm.
 12. The apparatus ofclaim 11, wherein said proximal portion of said outer wall has a firstthickness, and said distal portion of said outer wall has a secondthickness, said first thickness being greater than said second thicknessfor ensuring that said distal portion of said outer wall expands uponsupply of fluid to said inflatable balloon.
 13. The apparatus of claim12, further comprising a thickened ring member at an interface of saidproximal portion and said balloon of said outer wall for preventing saidproximal portion from inflating with said balloon upon supply of fluid.14. The apparatus of claim 12 wherein said inflatable balloon isintegral with said outer wall of said tubing.
 15. The apparatus of claim14 further comprising a thickened ring member formed integrally withsaid outer wall at an interface of said proximal portion and saidballoon of said outer wall for preventing said proximal portion frominflating with said balloon upon said supply of fluid.